News / Events

Poxel Announces Second Quarter and First Half 2018 Financial Update

LYON, France--(BUSINESS WIRE)--
POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for metabolic
disorders, including type 2 diabetes and non-alcoholic steatohepatitis
(NASH), today announced its cash position and revenue for the second
quarter and six months ended June 30, 2018.

As of June 30, 2018, cash and cash equivalents were EUR 94.4 million
(USD 110.1 million).

Poxel reported revenues of EUR 19.2 million for the quarter ended June
30, 2018 and EUR 37.5 million for the six months ended June 30, 2018
compared with no revenues during the same periods in 2017.

EUR millions

Q1

Q2

H1

Q1

Q2

H1

2018

2018

2018

2017

2017

2017

Roivant Agreement

8.1

-

8.1

-

-

-

Sumitomo Agreement

10.2

19.2

29.4

-

-

-

Total revenues

18.3

19.2

37.5

-

-

-

Unaudited data

The revenue reflects a portion of the EUR 36 million upfront payment
received from Sumitomo Dainippon Pharma relating to the strategic
corporate partnership announced on October 30, 2017 and the USD 35
million (EUR 28 million) upfront payment associated with the corporate
partnership announced with Roivant Sciences on February 12, 2018 net of
Poxel’s financial contribution to Roivant. In addition, the revenue also
reflects the Imeglimin Phase 3 program costs in Japan incurred during
the first semester that were re-invoiced to Sumitomo Dainippon Pharma.
Both the upfront payment from Sumitomo Dainippon Pharma and re-invoiced
costs of the Phase 3 Trials of IMeglimin for Efficacy
and Safety (TIMES) program are recognized according to the
percentage of completion for this program.

“I am very pleased to report that during the quarter we made substantial
progress for Imeglimin in Japan and continued to advance the three
pivotal Phase 3 TIMES trials. The TIMES 1 trial is fully enrolled, and
TIMES 2 and TIMES 3 are expected to be fully enrolled during the second
half of 2018. We are on track for the data readout in 2019, beginning
with the TIMES 1 efficacy study readout during the second quarter of
2019. We are continuing to work closely with our partner Sumitomo
Dainippon Pharma in preparing for the Japanese New Drug Application
submission in 2020,” said Thomas Kuhn, CEO of Poxel. “For the U.S. and
Europe, we are working closely with Roivant Sciences on Phase 3-related
activities with the goal to initiate the Phase 3 program in 2019.”

“For our second program, PXL770, we are completing the Phase 1 multiple
ascending dose study and the data is on track to be released in July. We
believe that PXL770 has the potential to treat liver diseases, such as
NASH, and could have the potential to treat additional metabolic
diseases,” added Thomas Kuhn. “We are preparing for the initiation of a
Phase 2a proof-of-concept program in patients with nonalcoholic fatty
liver disease (NAFLD), a condition where fat builds up in the liver and
of which NASH is a severe form. PXL770 may be differentiated from other
compounds in development for liver diseases since targeting AMPK
activation has the potential to provide benefits to the three key
pathophysiology processes involved in NASH development, which include
liver steatosis, inflammation and fibrosis. Additionally, it also could
treat NASH comorbidities, specifically targeting cardiovascular risk
factors, such as hyperglycemia, insulin resistance, dyslipidemia,
inflammation, and obesity. In parallel, we are actively working on
further leveraging our internal capabilities and are assessing
additional development opportunities in the metabolic area to broaden
our pipeline.”

Planned Presentations at the Following Upcoming EventsGoodwin,
Solebury Trout, and NASDAQ European Biotech Investor Day, July 19, 2018,
New York City, New YorkTrout CEO Roundtable, August 19, 2018,
Hamptons, New YorkEuropean Society of Cardiology 2018, August
25-29, 2018, Munich, GermanyH.C. Wainwright 20th Global
Investment Conference, September 4-6, 2018, New York City, New YorkAMPK
from Mechanisms to New Therapies, September 30-October 4,2018,
Ontario, Canada

Next financial press release: 2018 First Half Year Statement,
September 19, 2018

About ImegliminImeglimin is the first clinical candidate in
a new chemical class of oral agents called Glimins by the World Health
Organization. Imeglimin has a unique mechanism of action (“MOA”) that
targets mitochondrial bioenergetics. Imeglimin acts on all three key
organs which play an important role in the treatment of type 2 diabetes:
the liver, muscles and the pancreas, and it has demonstrated glucose
lowering benefits by increasing insulin secretion in response to
glucose, improving insulin sensitivity and suppressing gluconeogenesis.
This MOA has the potential to prevent endothelial and diastolic
dysfunction, which can provide protective effects on micro- and
macro-vascular defects induced by diabetes. It also has the potential
for protective effect on beta-cell survival and function. This unique
MOA offers the potential opportunity for Imeglimin to be a candidate for
the treatment of type 2 diabetes in almost all stages of the current
anti-diabetic treatment paradigm, including monotherapy or as an add-on
to other glucose lowering therapies.

About PXL770PXL770 is a first-in-class direct adenosine
monophosphate-activated protein kinase (AMPK) activator. AMPK is a
central regulator of multiple metabolic pathways leading to the control
of lipid metabolism, glucose homeostasis and inflammation. Based on its
central metabolic role, targeting AMPK offers the opportunity to pursue
a wide range of indications to treat chronic metabolic diseases,
including diseases that affect the liver, such as non-alcoholic
steatohepatitis (NASH).

About Poxel SAPoxel uses its development expertise in
metabolism to advance a pipeline of drug candidates focused on the
treatment of metabolic disorders, including type 2 diabetes and
non-alcoholic steatohepatitis (NASH). We have successfully completed the
Phase 2 clinical program for our first-in-class lead product, Imeglimin,
which targets mitochondrial dysfunction, in the U.S., Europe and Japan.
Together, with our partner Sumitomo Dainippon Pharma, we are conducting
the Phase 3 Trials IMeglimin for Efficacy and Safety
(TIMES) program for the treatment of type 2 diabetes in Japan.Our
partnerRoivant Sciences will be responsible for Imeglimin’s
development and commercialization in countries outside of Poxel’s
partnership with Sumitomo Dainippon Pharma, including the U.S. and
Europe. Our second program, PXL770, a first in class direct adenosine
monophosphate-activated protein kinase (AMPK) activator, is in Phase 1
and we plan on developing it for the treatment of NASH. PXL770 could
also have the potential to treat additional metabolic diseases. We
intend to generate further growth through strategic partnerships and
pipeline development. (Euronext: POXEL, www.poxelpharma.com)